Benz O Sthetic
FDA Label NDC 54162-929

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Benz O Sthetic (NDC 54162-929). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drugs facts, uses, directions, warnings, other ingredients, other information:, otc - keep out of reach of children, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drugs Facts

Active Ingredients                       Purpose
Benzocaine 20%........................Oral Anesthetic

Uses

Topical anesthetic for the temporary relief of occasional minor irritation and pain, associated with:
canker sores

  • sore mouth and throat
  • minor dental procedures
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • minor injury of the mouth and gums

Directions

May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat:
Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and use as directed by dentist/doctor.

Warnings


Do not use this product if patient has a history of allergy to local anesthetics
such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not
spray into or near eyes. Do not inhale.

Patient: When using extension tube, do not spray in the back of the throat
unless your dentist or doctor directed you to do so.

When using this product:

  • Avoid use near eyes
  • Do not use more than recommended dosage
  • Do not go beyond 7 days usage, unless directed by your doctor/dentist

    • Patient: Discontinue use and consult a physician if: sore mouth symptoms do
    not improve in 5 days; irritation, pain, or redness persists or worsens;
    swelling, rash, or fever develops.

Other Ingredients

Alcohol, benzyl alcohol, flavor, peppermint oil, polyethylene glycol, sodium saccharin

Other Information:

store at controlled room temperature 20-25°C (68-77°F)

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Warnings And Precautions

Caution:​ ​If accidental or excessive ingestion occurs (exceeds recommended dosage) contact a physician for immediate advice or call a Poison Control Center. 

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